Rinvoq

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upadacitinib

Authorised
This medicine is authorised for use in the European Union.

Overview

Rinvoq is a medicine that acts on the immune system (the body’s natural defences) and is used to treat:

  • adults with moderate to severe rheumatoid arthritis (a disease that causes inflammation of the joints) that cannot be controlled well enough with disease-modifying anti-rheumatic medicines (DMARDs) or if the patient cannot take these medicines. It can be used on its own or with methotrexate, another medicine that acts on the immune system;
  • adults with active psoriatic arthritis (inflammation of the joints associated with psoriasis, a disease causing red, scaly patches on the skin) that cannot be controlled well enough with DMARDs, or if the patient cannot take these medicines. Rinvoq can be used on its own or with methotrexate;
  • adults with active axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis, when X-ray shows the disease, and non-radiographic axial spondyloarthritis, when there are clear signs of inflammation but X-ray does not show disease. It is used when other treatments do not work well enough;
  • adults and children from 12 years of age with moderate to severe atopic dermatitis (also known as eczema, when the skin is itchy, red and dry) who can be treated with a medicine given by mouth or by injection;  
  • adults with ulcerative colitis (a disease that causes inflammation and ulcers in the lining of the bowel). Rinvoq is used to treat moderately to severely active ulcerative colitis when other medicines, including biological medicines, do not or no longer work, or if the patient cannot take them.

Rinvoq contains the active substance upadacitinib.

This EPAR was last updated on 22/09/2022

Authorisation details

Product details
Name
Rinvoq
Agency product number
EMEA/H/C/004760
Active substance
upadacitinib
International non-proprietary name (INN) or common name
upadacitinib
Therapeutic area (MeSH)
Arthritis, Rheumatoid
Anatomical therapeutic chemical (ATC) code
L04AA
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
AbbVie Deutschland GmbH & Co. KG
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
16/12/2019
Contact address

Knollstrasse 50
67061 Ludwigshafen am Rhein
Germany

Product information

27/07/2022 Rinvoq - EMEA/H/C/004760 - II/0016

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.

Psoriatic arthritis
RINVOQ is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.

Axial spondyloarthritis

Non-radiographic axial spondyloarthritis (nr-axSpA)

RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)

RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

Atopic dermatitis
RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

Ulcerative colitis
RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. 

Assessment history

Changes since initial authorisation of medicine

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